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Singapore HSA registration DE0509283

Diagast Anti-D, Anti-C, Anti-E, Anti-c, Anti-e Phenotyping Reagents

Singapore flagSingapore·CLASS D IVD·Diagast·Registered May 13, 2024
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Hematology
Registration information
Registration Number
DE0509283
Registration Date
May 13, 2024
Retention Due Date
May 12, 2025
Product description
Anti-D, Anti-C, Anti-E, Anti-c, Anti-e are in vitro diagnostic medical devices (IVDMD) intended to be used by healthcare professionals, biologists or lab technicians for the qualitative detection of red blood cell antigens in donor blood samples with anticoagulant (EDTA) using a microplate automated method. The phenotyping in donors is intended to ensure immunological compatibility and safe transfusion of blood and blood components.
Product Owner
Name
Diagast
Short Name
Diagast
Address
251 avenue Eugene Avinee, Eurasante Parc, 59120 LOOS FRANCE, FRANCE
Registrant
Name
BECKMAN COULTER SINGAPORE PTE. LTD.
Address
70 BENDEMEER ROAD, LUZERNE, #03-04, SINGAPORE 339940
Importer
Name
BECKMAN COULTER SINGAPORE PTE. LTD.
Address
70 BENDEMEER ROAD, LUZERNE, #03-04, SINGAPORE 339940
Model information
Model Name(s)
Anti-D (PK) Anti-C (PK1) Anti-E (PK1) Anti-c (PK1) Anti-e (PK1) CONTROL PK BROMELINE PK
Model Identifier(s)
B10334 B10337 B10338 B10339 B10340 B10350 B10351
About this record

Access comprehensive regulatory information for Diagast Anti-D, Anti-C, Anti-E, Anti-c, Anti-e Phenotyping Reagents in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0509283 and owned by Diagast. The device was registered on May 13, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS D IVD